Iovance Biotherapeutics Inc 2025年度报告

Ongoingimprovements in execution and deliveryculminated in our highest ever manufacturing successrate, largest number of patients treated and bestHYHU JURVV PDUJLQ LQ WKH IRXUWK TXDUWHU /RRNLQJahead, we expect remarkable growth in 2026 asZH GULYH DGRSWLRQ 2SHUDWLRQDO H[FHOOHQFH LQLWLDWLYHVLQFOXGLQJLQWHUQDOL]DWLRQRIDOOOLƮOHXFHOPDQXIDFWXULQJandoptimization of research and developmentDFWLYLWLHVDUHH[SHFWHGWRGULYHVLJQLƮFDQWDGGLWLRQDOimprovements in operating expenses, cost of salesDQGJURVVPDUJLQ Dear IovanceBiotherapeuticsShareholders, Notably,Proleukin®revenue also continued toJURZ DQG VXSSRUW WKH $PWDJYL WUHDWPHQW UHJLPHQTogether, these results underscore meaningful impactof Amtagvi for patients and establish our track recordLQ EXLOGLQJ D VWURQJ UHYHQXH EDVH ZLWK VLJQLƮFDQWJURZWK SRWHQWLDO WRZDUG PRUH WKDQ  ELOOLRQ LQ 86SHDNVDOHVZLWKIXUWKHUXSVLGHJOREDOO\ 2025 was transformative for advancing our mission to be the global leaderin TIL cell therapy innovation as we navigatedour commercial launch, achieved meaningfulclinical milestones and sharpened our focus onRSHUDWLRQDOH[FHOOHQFHDQGFRVWHưFLHQFLHVRQWKHSDWKWRIXWXUHSURƮWDELOLW\:HDUHVWHDGIDVWin our commitment to building durable, longWHUPSDWLHQWRXWFRPHVDQGVKDUHKROGHUYDOXH 2025represented an important year of globalUHJXODWRU\ SURJUHVV :H UHFHLYHG +HDOWK &DQDGDapprovalfor Amtagvi in advanced melanoma—RXU ƮUVW DSSURYDO RXWVLGH WKH 8QLWHG 6WDWHVšDQGadvancedregulatory strategies toward potentialapprovals in the United Kingdom, Australia, European8QLRQDQG6ZLW]HUODQG :LWK LQWHJUDWHG FOLQLFDO PDQXIDFWXULQJ DQG FRPPHUFLDOcapabilities across solid tumors, we are well positioned toHưFLHQWO\EURDGHQRXUUHDFKDQGLPSDFW:HDFKLHYHGVWURQJcommercial performance with Amtagvi® in 2025, expandingSDWLHQWDFFHVVWRƮUVWLQFODVV7,/WKHUDS\IRUSUHYLRXVO\WUHDWHGDGYDQFHGPHODQRPD'HPDQGIRU$PWDJYLLQFUHDVHGVWHDGLO\driving over a quarter billion dollars in product revenue duringWKH ƮUVW IXOO \HDU RI ODXQFK $GRSWLRQ EURDGHQHG DFURVV RXUexpanding network of authorized academic and communityWUHDWPHQWFHQWHUV5LVLQJSK\VLFLDQFRQƮGHQFHZDVEROVWHUHGE\ RXU XQSUHFHGHQWHG ƮYH\HDU FOLQLFDO GDWD DQDO\VLV DQGSRVLWLYHUHDOZRUOGSDWLHQWRXWFRPHVVXSSRUWLQJHDUO\WUHDWPHQWDQGORQJWHUPGXUDELOLW\ Alongside our commercial launch, we continued tovalidate the strength and scalability of our TIL platformin new indications and next generation therapies foradditional solid tumor indications with high unmetQHHG $V WKH FXUUHQW JOREDO OHDGHU LQ 7,/ WKHUDS\we are sustaining and extending our capabilities toLQQRYDWHRYHUWKHORQJWHUP 2XU UHJLVWUDWLRQDO SURJUDP LQ QRQVPDOO FHOO OXQJFDQFHU 16&/&  FRQWLQXHV WR DGYDQFH 3UHOLPLQDU\UHVXOWV IROORZLQJ RQHWLPH WUHDWPHQW ZLWK OLƮOHXFHOKDYH GHPRQVWUDWHG EHVWLQFODVV FOLQLFDO UHVSRQVHUDWHV DQG GXUDELOLW\ IXUWKHU VXSSRUWHG E\ )'$ IDVWtrackdesignation,in patients with nonsquamous16&/& DƷHU WKH\ IDLO IURQWOLQH VWDQGDUG RI FDUH :HDUH DOVR PRYLQJ LQWR D UHJLVWUDWLRQDO WULDO RI OLƮOHXFHOLQSUHYLRXVO\WUHDWHGSDWLHQWVZLWKDJJUHVVLYHGLưFXOWWRWUHDWDGYDQFHGVRƷWLVVXHVDUFRPDV “Ongoing improvementsin execution and deliveryculminated in our highest evermanufacturing success rate,largest number of patientstreated and best ever grossPDUJLQLQWKHIRXUWKTXDUWHULooking ahead, weexpect remarkablegrowth in 2026 as wedrive adoption.” /RRNLQJ DKHDG RXU QH[WJHQHUDWLRQ DSSURDFKHV DUH GHVLJQHGWR HQKDQFH HưFDF\ GXUDELOLW\ DQG VFDODELOLW\ IRU 7,/ WKHUDSLHVDFURVVQHZW\SHVRIVROLGWXPRUV7KHVHSURJUDPVLQFOXGHƮUVWLQKXPDQFOLQLFDOWULDOVRIRXUJHQHWLFDOO\PRGLƮHG7,/WKHUDS\,29 DQG RXU QH[WJHQHUDWLRQ ,/ FDQGLGDWH ,29:H DOVR H[SHFW WR VXEPLW DQ ,1' WKLV \HDU IRU ,29 DJHQHWLFDOO\HQJLQHHUHGLQGXFLEOH,/WHWKHUHG7,/WKHUDS\WRVXSSRUWD3KDVHEDVNHWWULDO I am extremely proud of our accomplishments as we advance ourvision to pioneer a new treatment approach with curative intentIRU VROLG WXPRUV 7KH TXDOLW\ RI RXU SHRSOH UHPDLQV D GHƮQLQJstrength of our organization and our ability to sustain leadershipLQ WKH ƮHOG $V ZH FRQWLQXH WR JURZ ZH UHPDLQ FRPPLWWHG WREXLOGLQJDGHHSEHQFKRIWDOHQWDQGIRVWHULQJDVWURQJSXUSRVHGULYHQFXOWXUH I am deeply grateful to our dedicated employees, healthcareprofessionals, collaboration partners, shareholders and—mostimportantly—the patients and their loved ones who inspire ourZRUNHYHU\GD\ FREDERICK G. VOGT, PH.D., J.D. ,QWHULP&(23UHVLGHQWDQG*HQHUDO&RXQVHO Iovance 2025 Highlights $PWDJYL&RPPHUFLDO/DXQFK %HVWLQFODVVFOLQLFDOGXUDELOLW\DQGUHDOZRUOGUHVSRQVHUDWHVDUHLQFUHDVLQJDGRSWLRQDQGVWUHQJWKHQLQJUHIHUUDOWUHQGVWRZDUGHDUOLHUWUHDWPHQW Five-year analysis of the C-144-01 trial of Amtagvi demo